Suction adapter for medical instrument

ABSTRACT

A suction adapter for use with first and second medical devices capable of accommodating suction, the adapter including a manifold having at least three ports and a flexible flow valve. The ports may include: a suction port configured for connecting to a suction source; a first device port configured for accommodating a first medical device, preferably an endoscope; and a second device port configured for accommodating a second medical device, preferably a suction biopsy device. The flexible flow valve has at least one opening and may be located between the first device port and both the second device port and the suction port.

BACKGROUND OF THE INVENTION

This application is a continuation-in-part of U.S. patent applicationSer. No. 09/079,168, filed May 15, 1998 now U.S. Pat. No. 6,331,165,entitled “Biopsy Instrument Having Irrigation and AspirationCapabilities,” which was a continuation-in-part of U.S. patentapplication Ser. No. 08/756,260, filed Nov. 25, 1996, now U.S. Pat. No.5,897,507, issued Apr. 27, 1999.

FIELD OF THE INVENTION

This invention relates broadly to endoscopic surgical instruments. Moreparticularly, this invention relates to an endoscopic biopsy forcepsinstrument with means for facilitating sample removal without withdrawalof the biopsy forceps instrument from an endoscope.

STATE OF THE ART

Endoscopic biopsy procedures are typically performed with an endoscopeand an endoscopic biopsy forceps device (bioptome). The endoscope is along flexible tube carrying fiber optics and having a narrow lumenthrough which the bioptome is inserted. The bioptome typically includesa long flexible coil having a pair of opposed jaws at the distal end andmanual actuation means at the proximal end. Manipulation of theactuation means opens and closes the jaws. During a biopsy tissuesampling operation, the surgeon guides the endoscope to the biopsy sitewhile viewing the biopsy site through the fiber optics of the endoscope.The bioptome is inserted the narrow lumen of the endoscope until theopposed jaws arrive at the biopsy site. While viewing the biopsy sitethrough the fiber optics of the endoscope, the surgeon positions thejaws around a tissue to be sampled and manipulates the actuation meansso that the jaws close around the tissue. A sample of the tissue is thencut and/or torn away from the biopsy site while it is trapped betweenthe jaws of the bioptome. Keeping the jaws closed, the surgeon withdrawsthe bioptome from the endoscope and then opens the jaws to collect thebiopsy tissue sample.

A biopsy tissue sampling procedure often requires the taking of severaltissue samples either from the same or from different biopsy sites.Unfortunately, most bioptomes are limited to taking a single tissuesample, after which the device must be withdrawn from the endoscope andthe tissue collected before the device can be used again to take asecond tissue sample. Several attempts have been made to provide aninstrument which will allow the taking of several tissue samples beforethe instrument must be withdrawn and the samples collected. Problems inproviding such an instrument include the extremely small size requiredby the narrow lumen of the endoscope and the fact that the instrumentmust be flexible in order to be inserted through the lumen of theendoscope. Thus, several known multiple sample biopsy instruments areprecluded from use with an endoscope because of their size and rigidity.These include the “punch and suction type” instruments disclosed in U.S.Pat. No. 3,989,033 to Halpern et al. and U.S. Pat. No. 4,522,206 toWhipple et al. Both of these devices have a hollow tube with a punch atthe distal end and a vacuum source coupled to the proximal end. A tissuesample is cut with the punch and suctioned away from the biopsy sitethrough the hollow tube. It is generally recognized, however, that drysuctioning tissue samples (i.e., without the use of an irrigating fluid)through a long narrow flexible bioptome is virtually impossible.

Efforts have been made to provide multiple sampling ability to aninstrument which must traverse the narrow lumen of an endoscope. Theseefforts have concentrated on providing a cylindrical storage space atthe distal end of the instrument wherein several tissue samples can beaccumulated before the instrument is withdrawn from the endoscope. U.S.Pat. No. 4,651,753 to Lifton, for example, discloses a rigid cylindricalmember attached to the distal end of a first flexible tube. Thecylindrical member has a lateral opening and a concentric cylindricalknife blade is slidably mounted within the cylindrical member. A secondflexible tube, concentric to the first tube is coupled to the knifeblade for moving the knife blade relative to the lateral opening in thecylindrical member. A third flexible tube having a plunger tip ismounted within the second flexible tube and a vacuum source (a syringe)is coupled to the proximal end of the third tube. A tissue sample istaken by bringing the lateral opening of the cylindrical member upon thebiopsy site, applying vacuum with the syringe to draw tissue into thelateral opening, and pushing the second flexible tube forward to movethe knife blade across the lateral opening. A tissue sample is therebycut and trapped inside the cylindrical knife within the cylindricalmember. The third flexible tube is then pushed forward moving itsplunger end against the tissue sample and pushing it forward into acylindrical storage space at the distal end of the cylindrical member.Approximately six samples can be stored in the cylindrical member, afterwhich the instrument is withdrawn from the endoscope. A distal plug onthe cylindrical member is removed and the six samples are collected bypushing the third tube so that its plunger end ejects the samples.

The device of the Lifton patent suffers from several recognizabledrawbacks. First, it is often difficult to obtain a tissue samplelaterally of the device. Second, in order to expedite the obtaining of alateral sample, a syringe is used to help draw the tissue into thelateral opening. However, this causes what was once a two-step procedure(position and cut), to become a three-step procedure (position, suction,cut). In addition, the use of a syringe requires an additional hand.Third, the Lifton patent adds a fourth step to the biopsy procedure byrequiring that the tissue sample be pushed into the storage space. Thus,in all, the Lifton patent requires substantial effort on the part of thesurgeon and an assistant and much of this effort is involved in pushingtubes, an action which is counter-intuitive to classical biopsysampling. The preferred mode of operation of virtually all endoscopictools is that a gripping action at the distal end of the instrument iseffected by a similar action at the proximal end of the instrument.Classical biopsy forceps jaws are closed by squeezing a manual actuationmember in a syringe-like manner.

A more convenient endoscopic multiple sample biopsy device is disclosedin U.S. Pat. No. 5,171,255 to Rydell. Rydell provides a flexibleendoscopic instrument with a knife-sharp cutting cylinder at its distalend. A coaxial anvil is coupled to a pull wire and is actuated in thesame manner as conventional biopsy forceps. When the anvil is drawn intothe cylinder, tissue located between the anvil and the cylinder is cutand pushed into a storage space within the cylinder. Several samples maybe taken and held in the storage space before the device is withdrawnfrom the endoscope. While the device of Rydell is effective in providinga multiple sample tool where each sample is obtained with a traditionaltwo-step procedure (position and cut), it is still limited to lateralcutting which is often problematic. Traditional biopsy forceps providejaws which can grasp tissue frontally or laterally. Even as such, it isdifficult to position the jaws about the tissue to be sampled. Lateralsampling is even more difficult.

A multiple sample biopsy forceps of a more traditional form is disclosedin co-owned U.S. Pat. No. 5,542,432 to Slater et al. Slater et al.discloses an endoscopic multiple sample biopsy forceps having a jawassembly which includes a pair of opposed toothed jaw cups each of whichis coupled by a resilient arm to a base member. The base member of thejaw assembly is mounted inside a cylinder and axial movement of one ofthe jaw assembly and cylinder relative to the other draws the arms ofthe jaws into the cylinder or moves the cylinder over the arms of thejaws to bring the jaw cups together in a biting action. The arms of thejaws effectively form a storage chamber which extends proximally fromthe lower jaw cup and prevents accumulated biopsy samples from beingsqueezed laterally out from between the jaws during repeated opening andclosing of the jaws and the lower jaw cup enhances movement of thebiopsy samples into the storage chamber. The device can hold up to foursamples before it must be retrieved out of the endoscope. However, insome biopsy procedures it is sometimes desirous to retrieve more. Inaddition, it has been found that samples within the chamber can sticktogether and make determinations of which sample came from which biopsysite somewhat difficult.

U.S. Pat. No. 5,538,008 to Crowe discloses a multiple sample bioptomewhich purports to take several samples and to transfer each sample bywater pressure through a duct to the proximal end of the instrument,where each sample can be individually retrieved. The device includes aplastic jaw set biased in an open position and coupled to the distal endof an elongate tube, up to seven feet long. The tube defines a duct. Asleeve extends over the tube and a water flow passage is providedbetween the tube and the sleeve. An aperture is provided in the tube topermit the water flow passage to meet the duct at the distal end of thetube. Withdrawing the tube into the sleeve is disclosed to force thejaws closed and enable a sample to be cut from tissue and lodge in theduct. The water flow passage is disclosed to enable water to flow underpressure from the proximal end of passage to the distal end of thepassage, through the aperture and into the distal end of the duct and tobe aspirated to the proximal end of the duct, thereby transferring withit any sample contained in the duct to the proximal end where the samplecan be retrieved.

While on paper the Crowe device is appealing, in practice the design isimpractical and flawed. For example, it would be very difficult, if notimpossible, to slide the elongate tube, up to seven feet in length,relative to a sleeve of substantially the same length. It would also bedifficult to maintain an unobstructed water flow passage between thetube and sleeve as the tube and sleeve curve and bend through the body.Furthermore, in order for the jaws to cut a tissue sample, the tube andjaws must be drawn into the sleeve, thereby undesirably pulling the jawsaway from the tissue to be sampled.

In general, endoscopy suites have a single source of suction forconnection to an endoscope and/or endoscopic devices. In addition, mostendoscopes have trumpet type valves that control inflation and deflationof the intestinal tract during an endoscopic procedure. These valves arein the normally open position, which means that they are open to thesurrounding environment, allowing air to freely flow through them. Thismakes it difficult to connect an endoscopic device capable ofaccommodating suction in parallel with an endoscope. The constant leakthrough the endoscope considerably reduces the ability of the suctionsource to supply suction to the suction endoscopic device.

One possible way to overcome this problem would be to connect both theendoscope and the suction endoscopic device to the suction source via atwo-way valve. A two-way valve would allow flow of suction to only onedevice at a time. The drawbacks to using a two-way valve are theinconvenience of manually switching the two-way valve every time thatsuction is needed by either device or the costs associated withimplementing automatic switching.

Another possible solution would be to use a tee-connector with arestricted opening, such as a small hole, on the endoscope's port. Therestriction would allow for continuous flow to the normally open device(e.g. the endoscope), yet provide adequate pressure differential to thesecond suction device without the need for switching. A variation ofthis method would consist of a tee-connector (or a manifold if more thantwo suction endoscopic devices are to be accommodated) where all theports for the suction endoscopic devices would have such restrictions.If the restrictions are of identical proportions, all the open suctionports would present similar flow and pressure differential conditions.By modifying the size of the restriction openings and noting that theflow is directly proportional and the pressure differential is inverselyproportional to the size of the restriction opening, the flow andpressure differentials could be controlled. The primary drawback tousing such a restriction on the port for the endoscope is that a smallopening could easily clog, since the main function for suction in theendoscope is to eliminate fluids and solids, such as waste or smallresections, from the patient.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide an endoscopicbiopsy forceps instrument which permits numerous tissue samples to betaken from a patient without removing the forceps from within thepatient.

It is another object of the invention to provide an endoscopic biopsyforceps instrument which can individually retrieve each of severaltissue samples from the forceps without removing the forceps from thepatient.

It is a further object of the invention to provide an endoscopic biopsyforceps instrument which can take tissue samples located either distallyor laterally relative to the instrument.

It is an additional object of the invention to provide an endoscopicbiopsy forceps instrument which irrigates the forceps and aspiratestissue samples contained therein.

It is also an object of the invention to provide an endoscopic biopsyforceps instrument which includes a reservoir to catch samples aspiratedthrough the instrument.

It is an even further object of the invention to provide a suctionadapter having ports for the parallel connection of an endoscope withanother endoscopic device capable of accommodating suction whereinadequate suction is supplied to both the endoscope and the otherendoscopic device and switching between ports is not necessary.

It is an additional object of the invention to provide a suction adapterhaving ports for the parallel connection of an endoscope with anotherendoscopic device wherein a flow restricting valve allows for thepassage of relatively large pieces of debris while generally maintaininga desired pressure differential.

In accord with these objects which will be discussed in detail below, anendoscopic biopsy forceps instrument is provided and generally includesa proximal actuation handle, a distal forceps assembly, a control membercoupled to the proximal actuation handle and the distal forcepsassembly, and a flexible multi-lumen tubular member having an irrigationconduit, an aspiration conduit, and a control conduit which receives thecontrol member.

According to a preferred embodiment of the invention, the proximalactuation handle includes a shaft and a spool slidably mounted on theshaft. The actuation handle is also provided with a proximal irrigationpassage, a sample chamber, a sample catch member, and a pinch valvewhich regulates irrigation and aspiration. The proximal irrigationpassage is coupled to the irrigation conduit and to an irrigationcoupling tube. The sample chamber is coupled to the aspiration conduitand to an aspiration coupling tube. The sample catch member includes ascreen which is inserted into the sample chamber and filters out tissuesamples from the aspirated fluid. The irrigation coupling tube and theaspiration coupling tube extend through the pinch valve which operatesto control the flow of fluid through the tubes. The actuation handle iscoupled to the proximal ends of both the flexible tubular member and thecontrol member and moves the control member relative to the tubularmember.

The distal assembly is coupled to the distal end of the tubular memberand includes a hollow jaw cup coupled over the distal end of theaspiration conduit and a hollow movable jaw pivotally coupled adjacentthe irrigation conduit. The jaw cup is preferably formed from a hardplastic and has a blunt cutting surface, while the movable jaw ispreferably a metal jaw with a sharp cutting edge. The movable jaw isfurther coupled to the control member, such that actuation of theactuation handle moves the movable jaw relative to the jaw cup, andthereby moves the jaws from an open position to a closed position.Moving the hollow jaws to a closed position provides a substantiallyfluid tight coupling between the irrigation and aspiration conduits.

It will be appreciated that the distal end of the instrument is broughtinto contact with tissue of which a sample is required and the actuationhandle is actuated to close the jaws and cut off a tissue sample. Withthe jaws in a closed position, water is irrigated through the irrigationconduit to the jaws at the distal end of the instrument and aspiratedfrom the jaws to the proximal end of the instrument through theaspiration conduit, such that the sample cut by the jaws is aspiratedwith the water. As the water is aspirated it passes through the chamberand the sample is filtered onto the screen. The screen may easily beremoved to retrieve the sample. It will be further appreciated that theentire procedure of cutting a sample and retrieving the sample may beperformed without removing the endoscopic biopsy forceps instrument fromits location within the body.

According to one embodiment of the biopsy forceps instrument, thetubular member is ovoid in shape and defines a control conduit, anirrigation conduit, and an aspiration conduit. The distal forcepsassembly includes a movable jaw, and a substantially rigid molded collarwhich is provided with a proximal socket-like coupling means forcoupling the tubular member thereto, a fixed jaw cup, a distalirrigation passage, and a control passage. The collar is of similardiameter to the endoscope and is designed to be coupled to the outsideof the distal end of an endoscope by a silicone rubber sock. The movablejaw is pivotally mounted on the molded collar and is movable relative tojaw cup. The tubular member is coupled in the socket. A control wireextends through the control conduit and the control passage is coupledto the two holes in the movable jaw.

According to a second embodiment, the biopsy forceps instrument includesa tubular member which defines an aspiration conduit having a circularcross section, an irrigation conduit having a kidney-shaped crosssection, and two control conduits. The distal assembly includes astationary jaw bonded to the distal end of the tubular member, and amovable jaw. The stationary jaw includes a hollow jaw cup, a clevismember and two proximal ramps. The jaw cup is located over theaspiration conduit, and the clevis and the proximal ramps extend fromthe jaw cup over the irrigation conduit. The movable jaw is coupled tothe clevis and is guided along the proximal ramps. The two controlconduits exit the distal end of the tubular member lateral of theproximal ramps. A central portion of a control member is coupled to themovable jaw and each end of the control member extends through thecontrol conduits to the proximal end of the instrument.

According to a third embodiment of the biopsy forceps instrument, theinstrument includes a tubular member which defines an aspiration conduithaving a circular cross section and an irrigation conduit having acrescent-shaped cross section. The distal assembly is substantiallysimilar to the second embodiment. The proximal ramps abut and partiallycover the irrigation conduit to define two entrances into the irrigationconduit for the control members. A distal end of each control member iscoupled to the movable jaw and the control members extend through theentrances and into the irrigation conduit. The entrances aresufficiently small such that when the jaws are in a closed position andfluid is irrigated through the irrigation conduit to the distalassembly, substantially all of the fluid passes through the irrigationconduit and into the jaws; i.e. only an insubstantial amount of thefluid irrigated through the irrigation conduit exits through theentrances formed by the ramps.

According to another aspect of the present invention, a suction adapterfor use with first and second medial devices capable of accommodatingsuction is provided that generally includes at least three ports and aflexible flow valve. According to an embodiment, the suction adapter mayinclude a manifold having at least three ports. The ports may include asuction port configured for connecting to a suction source, a firstdevice port configured for accommodating the first medical device, and asecond device port configured for accommodating the second medicaldevice. The flexible flow valve has an opening and may be locatedbetween the first device port and both the second device port and thesuction port.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a broken perspective view of a first embodiment of anendoscopic biopsy forceps instrument according to the invention;

FIG. 2 is a broken perspective view of the proximal end of the firstembodiment of the invention;

FIG. 3 is a broken perspective view of the sample chamber of the firstembodiment of the invention;

FIG. 4 is a perspective view of the front side of the sample catchmember of the first embodiment of the invention;

FIG. 5 is a perspective view of the back side of the sample catch memberof the first embodiment of the invention;

FIG. 6 is an enlarged broken perspective view of the tubular member ofthe first embodiment of the invention;

FIG. 7 is an enlarged broken perspective view of the distal assembly ofthe first embodiment of the invention with the jaws in an open position;

FIG. 8 is an enlarged broken perspective view of the distal assembly ofthe first embodiment of the invention with the jaws in a closedposition;

FIG. 9 is a bottom end view of FIG. 8;

FIG. 10 is a cross section across line 10-10 of FIG. 7;

FIG. 11 is cross section across line 11-11 of FIG. 8;

FIG. 12 is a broken perspective view of the distal assembly of the firstembodiment illustrating an alternate control member configuration;

FIG. 13 is a broken perspective view of the distal assembly of the firstembodiment illustrating another alternate control member configuration;

FIG. 14 is a broken perspective view of a second embodiment of anendoscopic biopsy forceps instrument of the invention;

FIG. 15 is an enlarged broken transparent perspective view of thetubular member of the second embodiment of the invention;

FIG. 16 is an enlarged cross section across line 16-16 of FIG. 15;

FIG. 17 is an enlarged broken perspective view of the distal assembly ofthe second embodiment of the invention with the jaws in an openposition;

FIG. 18 is a cross section across line 18-18 of FIG. 17;

FIG. 19 is an enlarged broken perspective view of the distal end of thesecond embodiment of the invention with the biopsy jaws in a closedposition;

FIG. 20 is a cross section across line 20-20 of FIG. 19;

FIG. 21 is an enlarged broken transparent perspective view of thetubular member of the third embodiment of the invention;

FIG. 22 is an enlarged cross-section across line 22-22 of FIG. 21;

FIG. 23 is a enlarged broken perspective view of the distal end of athird embodiment of the invention with the jaws in an open position;

FIG. 24 is a transparent perspective view of a first embodiment of asuction adapter;

FIG. 25A is a cross-section of a second embodiment of a suction adapter;

FIG. 25B is an enlarged cross-section of a flow restricting valve of thesuction adapter of FIG. 25A;

FIG. 26 is a detail of the flow restricting valve as seen from thedistal end side of the suction adapter of FIG. 24;

FIG. 27 is a detail of the flow restricting valve as seen from theproximal end side of the suction adapter of FIG. 24;

FIG. 28 is a perspective view of the suction adapter of FIG. 24;

FIG. 29A is a transparent view of an optional embodiment of a flowrestricting valve, as seen from the upstream side;

FIG. 29B is a non-transparent view of the flow restricting valve of FIG.29A, also as seen from the upstream side;

FIG. 29C is a perspective view of the flow restricting valve of FIG.29A, as seen from the upstream side;

FIG. 29D is a perspective view of the flow restricting valve of FIG.29A, as seen from the downstream side;

FIG. 30A is a transparent view of another optional embodiment of a flowrestricting valve, as seen from the upstream side;

FIG. 30B is a non-transparent view of the flow restricting valve of FIG.30A, also as seen from the upstream side;

FIG. 30C is a perspective view of the flow restricting valve of FIG.30A, as seen from the upstream side;

FIG. 30D is a perspective view of the flow restricting valve of FIG.30A, as seen from the downstream side;

FIG. 31A is a transparent view of a further optional embodiment of aflow restricting valve, as seen from the downstream side;

FIG. 31B is a perspective view of the flow restricting valve of FIG.31A, also as seen from the downstream side;

FIG. 32A is a transparent view of an additional optional embodiment of aflow restricting valve, as seem from the downstream side;

FIG. 32B is a perspective view of the flow restricting valve of FIG.32A, also as seem from the downstream side;

FIG. 33 is a cross-section of another embodiment of a suction adapter;and

FIG. 34 is a cross-section of the suction adapter of FIG. 25A connectedto a suction source and first and second medical devices.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to FIG. 1, a multiple sample biopsy forceps instrument 10 isshown. The biopsy forceps instrument generally includes a proximalactuation handle 12, a flexible multi-lumen tubular member 14, a pullwire 20, and a distal assembly 22. Several coupling tubes are preferablyprovided to couple the proximal actuation handle 12 to the tubularmember 14 and to irrigation and aspiration means. In particular, acontrol coupling tube 23, first and second irrigation coupling tubes 24,25 and first and second aspiration coupling tubes 26, 27 are provided.

The proximal actuation handle 12 includes a shaft 30 having a transverseslot 32 and a spool 34 slidably mounted on the shaft and having atransverse bar (not shown) extending through the slot 32, as is commonin the art. The actuation handle 12 is provided with a sample chamber42, a sample catch member 44, and a pinch valve 45 which regulatesirrigation and aspiration. Turning to FIG. 2, the sample chamber 42includes irrigation connectors 46, 47 which couple the first irrigationcoupling tube 24 to the second irrigation coupling tube 25. The samplechamber 42 also includes first and second aspiration connectors 48, 49which couple the first aspiration coupling tube 26 to the secondaspiration coupling tube 27. Referring to FIGS. 3 through 5, the samplecatch member 44 includes a handle portion 52, an engagement portion 54which removably engages the sample catch member 44 to the sample chamber42, and a screen 56. The screen 56 extends through the sample chamber 42between the first and second aspiration connectors 48, 49. The screen 56includes a front side 58 and a back side 60 and is provided with aplurality of perforations 62 which are preferably frustoconical in shapeand expand from the front side 58 to the back side 60. The firstirrigation coupling tube 26 and the first aspiration coupling tube 27extend through the pinch valve 45 which operates to control the flow offluid through the tubes 26, 27. The pinch valve is biased to clampclosed the first irrigation coupling tube 26 and the first aspirationcoupling tube 27, i.e., to collapse the tubes on top of each other.Pressing downward on the pinch valve 45 with a practitioner's fingercounters the bias of the pinch valve to permit fluid flow through thefirst irrigation coupling tube 26 and the first aspiration coupling tube27.

Turning to FIGS. 6 and 7, and in accord with the first embodiment of theinvention, the tubular member 14 is preferably an ovoid multi-lumenextrusion. The tubular member includes a proximal end 66, a distal end68, a control conduit 70, an irrigation conduit 72, and an aspirationconduit 74, each of which extends through the tubular member to thedistal assembly 22. At the proximal end 66 of the tubular member, thecontrol conduit 70 is coupled to the control coupling tube 23, theirrigation conduit 72 is coupled to the second irrigation coupling tube25 and the aspiration conduit 74 is coupled to the second aspirationcoupling tube 27.

Referring to FIGS. 7 through 9, the distal assembly 22 includes asubstantially rigid molded collar 80 and a hollow movable jaw 90. Thecollar 80 is preferably made from a unitary piece of polycarbonate, aglass-filled polycarbonate, a hard grade styrene, or other plastic,while the movable jaw 90 is preferably made from cast metal. The collarincludes a central opening 81, a circumferential channel 83, a distallyextending control passage 82, a distally extending hollow jaw mount 84,a distally extending hollow stationary jaw 88, and a proximal socket 86.The central opening 81 of the collar 80 is of similar diameter to theouter diameter of the endoscope and is designed to couple the collar tothe outside of the distal end of an endoscope. The circumferentialchannel 81 receives a portion of a silicone rubber sock (not shown),which is used to secure the collar 80 to the endoscope.

The stationary jaw 88 preferably includes a blunt edge or lip 92. Themovable jaw 90 is pivotally mounted at a pivot 94 on the jaw mount 84and is pivotable relative to stationary jaw 88. The movable jaw 90 ispreferably provided with a sharp cutting edge 98, a stop 100 forlimiting the extent to which the movable jaw pivots away from thestationary jaw 88, and two jaw holes 102, 104, for receiving a pull wire20, as described below.

Referring to FIGS. 9 through 11, the proximal socket 86 is aligned withthe control passage 82, the jaw mount 84 and the stationary jaw 88, andis designed to receive the distal end 68 of the flexible tubular member14. The distal end 68 of the tubular member is secured in the proximalsocket 86, preferably using an adhesion bonding agent, such that thecontrol passage 82 is coupled to the control conduit 70, the jaw mount84 is coupled substantially fluidtight to the irrigation conduit 72, andthe stationary jaw 88 is coupled substantially fluidtight to theaspiration conduit 76.

Turning back to FIGS. 1, 6, 7 and 10, a central portion of the pull wire20 extends through the jaw holes 102, 104 and the ends of the pull wire20 extend through the control passage 82, the control conduit 70, andthe control coupling tube 23 to the spool 34. Referring to FIG. 12,alternatively the pull wire 20 a forms a secure loop 106 a through thejaw holes 102 a, 104 a by doubling back on itself and forming a twist108 a. Referring to FIG. 13, in yet another alternative, two pull wires20 b, 21 b may be used, the distal end of each pull wire being coupledto a jaw hole 102 b, 104 b by a Z-bend 110 b, 112 b and extendingthrough the control passage 82 b.

Referring to FIGS. 1, 7, and 8, it will be appreciated that movement ofthe spool 34 relative to the shaft 30 results in movement of the pullwire 20 relative to the tubular member 14 and consequently moves themovable jaw 90 relative to the stationary jaw 88 such that the jaws open(FIG. 7) and close (FIG. 8). Referring to FIGS. 7 through 11, when thestationary and movable jaws 88, 90 are in a closed position asubstantially fluidtight passage is formed therebetween. Because thestationary jaw 88 is coupled to the aspiration conduit 74 and themovable jaw 90 is coupled over the irrigation conduit 72, asubstantially fluidtight coupling of the irrigation and aspirationconduits is achieved.

In use, it will be appreciated that the distal end of the endoscope towhich the collar 80 is coupled is maneuvered adjacent the desired tissuefor sampling and the distal assembly is brought into contact with tissue110 (FIGS. 10 and 11). The actuation handle 12 is actuated to close thejaws 88, 90 and cut off a tissue sample 112. When the jaws 88, 90 are ina closed position, the irrigation means and the aspiration means areactivated and the first proximal irrigation coupling tube and the firstproximal aspiration coupling tube 24, 26 are released from the clampingaction of the pinch valve 45 by depressing the pinch valve. Irrigatingfluid is thereby permitted to flow through the first and second proximalirrigation coupling tubes 24, 26, through the irrigation conduit 72 andthe hollow jaw mount 84, and to the jaws 88, 90 at the distal end of theinstrument. The fluid flows through the jaws and is aspirated back tothe proximal end of the instrument such that the sample held within thejaws is aspirated with the water. Turning back to FIGS. 2 through 6, asthe water is aspirated through the aspiration conduit 74 and into thesample chamber 42, the sample is filtered onto the screen 58. Thefrustoconical shape of the perforations 62 permits increased fluid flowthrough the perforate screen while preventing the tissue sample frompassing through the screen. Irrigation and aspiration means areinterrupted by releasing the pinch valve 45 such that the pinch valveclamps down on the first proximal irrigation and aspiration couplingtubes 24, 26 and causes the tubes to collapse on top of each other. Thescreen 58 may easily be removed to retrieve the sample by gripping thehandle portion 52 of the sample catch member 44 and pulling the samplecatch member from the sample chamber 42. The sample is recovered fromthe screen, and the sample catch member is reinserted into the samplechamber to continue the procedure. It will be further appreciated thatthe entire procedure of cutting a sample and retrieving the sample maybe performed without removing the endoscopic multiple sample biopsyforceps instrument from its location within the body. Unlimitedsubsequent samples may be obtained in an identical manner.

Turning to FIGS. 14 and 15, a second embodiment of a multiple samplebiopsy forceps instrument 210 is shown. The instrument includes aproximal actuation handle 212, a flexible multi-lumen tubular member214, a pull wire 220, and a distal assembly 222. Several coupling tubesare preferably provided to couple the proximal actuation handle 212 tothe tubular member 214 and to irrigation and aspiration means. Inparticular, a Y-shaped control coupling tube 223, first and secondirrigation coupling tubes 224, 225, and first and second aspirationcoupling tubes 226, 227 are provided.

The proximal actuation handle 212 is substantially similar to the firstembodiment (with like parts having numbers incremented by 200).Referring to FIGS. 15, 16 and 17, the tubular member 214 is preferably amulti-lumen multi-layer extrusion, and preferably includes a first metalbraid 276 beneath the outermost layer to add desired stiffness to thetubular member. If desired, a second metal braid 277 may be additionallyprovided around the aspiration conduit 274 to stiffen and support theaspiration conduit 274. The tubular member 214 has a proximal end 266, adistal end 268, two control conduits 270, 271, an irrigation conduit272, and an aspiration conduit 274, each of the conduits 270, 271, 272,274 extending through the tubular member to the distal assembly 222. Theaspiration conduit 274 has a substantially circular cross section. Theirrigation conduit 272 has a generally kidney-shaped cross section andis separated from the aspiration conduit 274 by a membrane 275. Thecontrol conduits 270, 271 are preferably situated one on either end ofthe membrane 275.

Referring to FIGS. 17 through 20, the distal assembly 222 according tothe second embodiment of the invention includes a stationary jaw 281coupled, preferably by adhesion bonding, to the distal end 268 of thetubular member. The stationary jaw 281, preferably made of plastic,includes a jaw cup 288, an integral central clevis 293 and integralproximal ramps 295, 296. The jaw cup 288 is located over the aspirationconduit 274 and preferably has a blunt cutting surface or lip 292. Thecentral clevis 293 and proximal ramps 295, 296 extend from thestationary jaw 281 and abut and partially cover the irrigation conduit.A movable jaw 290, preferably made of metal, is provided with a sharpcutting edge 298, defines two jaw holes 302, 304 for receiving a pullwire 220, and is provided with two bosses 312, 314 for mounting the jaw.The bosses 312, 314 loosely engage the central clevis 293 and a pivotpin 294 extends through the bosses and the central clevis. The ramps295, 296 of the stationary jaw 281 guide the movable jaw 290 whenopening and closing and assist to form a substantially fluidtightpassage between the movable jaw 290 and the stationary jaw cup 288 whenthe jaws are in a closed position. A central portion of the pull wire220 which is perpendicular to the longitudinal axis of the instrumentextends through the jaw holes 302, 304 and the ends of the pull wireextend into the control conduits 270,271. Turning back to FIG. 15, theY-shaped coupling tube 223 facilitates alignment of the ends of the pullwire 220 for coupling the pull wire to the proximal actuation handle.The pull wire 220 may be coated, e.g., in a plastic, to inhibit the pullwire from cutting into the tubular member.

Referring to FIGS. 18 and 20, the distal end 268 of the tubular memberis inserted through the lumen of an endoscope to a biopsy site. The jawsare moved into a closed position cutting off a tissue sample and furtherproviding a substantially fluidtight coupling between the irrigation andaspiration conduits 272,274. While it appears from the illustrations ofFIGS. 18 and 20 that the irrigation conduit 272 is obstructed at thedistal end by clevis 293, it will be appreciated that the irrigationconduit 272 is substantially wider than the clevis and that fluid mayflow around the clevis to the aspiration conduit 274.

Turning now to FIGS. 21 through 23, a third embodiment of a multiplesample biopsy forceps, substantially similar to the second embodiment(with like parts having numbers incremented by another 200) is shown.The tubular member 414 has a proximal end 466, a distal end 468, anirrigation conduit 472, and an aspiration conduit 474. The aspirationconduit 474 has a substantially circular cross section, while theirrigation conduit 472 has a generally crescent-shaped cross section. Acontrol coupling tube 423 is coupled to the second irrigation couplingtube 425. Two pull wires 420, 421 extend through the control couplingtube 423, pass through a substantially fluidtight valve (not shown)coupling the control coupling tube 423 and the second irrigationcoupling tube 425, enter into the second irrigation coupling tube 425,and extend through the irrigation conduit 472 to the distal end 468 ofthe tubular member. An aspiration coupling tube 427 is coupled to theaspiration conduit 474.

Referring to FIG. 23, the distal assembly 422 of the third embodiment ofthe invention includes a stationary jaw 481 bonded to the distal end 468of the tubular member, and a movable jaw 490 coupled thereto. Thestationary jaw 481 includes a jaw cup 488, an integral central clevis493, and ramps 495, 496. The jaw cup abuts the distal end of the tubularmember and is positioned over the aspiration conduit 474 and preferablyhas a blunt cutting surface or lip 492. The central clevis 493 and ramps495, 496 extend from the stationary jaw 481 and abut and partially coverthe irrigation conduit 474. A movable jaw 490, preferably made of metal,is provided with a sharp cutting edge 498, defines two jaw holes 402,404 for receiving a pull wire 420, and is provided with two bosses 512,514 for mounting the jaw. The bosses 512, 514 loosely engage the centralclevis 493 and a pivot pin 494 extends through the bosses and thecentral clevis. By partially covering the irrigation conduit, the rampsform entrances 499, 500 for the pull wires, as described below. Themovable jaw 490 rides on the proximal ramps 495, 496 when moving from anopen to a closed position. The pull wires 420, 421 are coupled to thejaw holes 502, 504 by a Z-bend 506, 507 and extend through the entrances499, 500 into the irrigation conduit 472, through a portion of thesecond irrigation coupling tube 425, and further into a control couplingtube 423 coupled thereto. The entrances 499, 500 are sufficiently smallthat only an insubstantial amount of fluid exits from the irrigationconduit when the jaws are in a closed position and irrigant is forcedthrough the irrigation conduit 474 to the distal assembly.

Turning to FIGS. 24-32, several aspects that relate to a suctionadapter, which allows any two or more medical devices to share a singlesuction source, are illustrated. For example, a suction adapter, forinstance as shown in FIG. 24, allows a multiple sample biopsy forceps toshare the same suction source with an endoscope.

FIGS. 24 and 25A show two embodiments of a suction adapter 600. In eachembodiment, a suction adapter 600 may consist of a manifold 602 having adistal end 604 and a proximal end 606. The manifold 602 may be equippedwith at least three ports: a suction source port 610, a first deviceport 612, and a second device port 614. The suction source port 610 isconfigured for connection to a suction or vacuum source (not shown). Thefirst device port 612 is separated from the suction source port 610 andthe second device port 614 by a flow restricting valve 618. The firstdevice port 612 is configured to accommodate a first device capable ofaccommodating suction, preferably an endoscope. The second device port614 is configured to accommodate a second such device capable ofaccommodating suction, preferably a suction biopsy forceps (not shown).In the general case, the manifold could include more than three ports,and more particularly, additional device ports can be included. Theseother device ports could either be separated from the suction sourceport and any other device ports by flow restricting valves or beconfigured for accommodating suction without an intervening flowrestricting valve. In a preferred embodiment, the second device mayincorporate a flow restricting valve that is normally closed such thatin an idle configuration the device does not draw suction, and onlydraws suction when the valve is selectively opened.

FIG. 34 illustrates suction adapter 600, a source of suction 1600, afirst medical device 2600, and a second medical device 3600. Source ofsuction 1600 is connected to suction source port 610, first device port612 is accommodating first medical device 2600, and second device port614 is accommodating second medical device 3600.

As shown in FIGS. 25-27, the flow restricting valve 618 may be embodiedas a tricuspid valve. The flow restricting valve 618 may include aflexible membrane 620 split by cuts 622 forming flaps 624 and having atleast one opening 626. In a preferred embodiment, the flexible membrane620 would be split by at least three radial cuts 622 to form three flaps624, although a valve having more than three cuts and three flaps fallswithin the scope of the invention. The cuts need not be radial noridentical in, for example, size or shape. Also in a preferredembodiment, the flexible membrane 620 is conical, but other shapes arewithin the scope of the invention. For example, the flexible membranecould alternatively be flat, dome-shaped, or a multi-faceted prism.Further, the opening 626 could be of any regular or irregular shape, andthe opening 626 could be centrally located but need not be, and therecould be more than one opening.

In alternative aspects, as shown in FIG. 24 and in greater detail inFIGS. 29A-29D and 30A-30D, the flow restricting valve 618 could includeflaps formed, not by cuts, but by folds. In another aspect, as shown indetail in FIGS. 31A and 31B, the flow restricting valve 618 couldinclude an even number of flaps, wherein the flaps are staggered, i.e.,adjacent flaps have dissimilar geometries, while every other flap issubstantially identical. In a further aspect, as shown in detail inFIGS. 32A and 32B, the flow restricting valve 618 could include a seriesof prismatically-shaped flaps. Thus, it is conceivable that thethickness of any individual flap could vary. In yet another aspect, theflow restricting valve may consist of an elastic membrane with at leastone opening. The at least one opening may elastically flex to allow theestablishment of the desired pressure differential between the ports.Moreover, the opening could be a hole, slit, or any other regular orirregular shaped opening. In addition, the overall shape of the flowrestricting valve 618 could be a generally conical, flat, domed,multi-faceted, or other regular or irregular shape.

By controlling the physical design of the valve, the appropriate balancebetween flow and pressure differential may be achieved. For instance,the design parameter that control the flexibility of the membranematerial and the dimensions of the overall valve may be varied. Also,for instance, the design parameters that control the geometry andconfiguration of the individual flaps and the cross-sectional area andconfiguration of the openings and of the gaps, if any, between the flapsmay be varied. The flow restricting valve 618 eliminates any need forproviding a switch to cycle or switch between ports.

Moreover, the flow restricting valve 618 is preferably self-adjusting.In other words, because of the flexible nature of the valve and thevalve flaps 624, objects or debris larger than the opening 626 can passthrough. Once the debris has cleared the flow restricting valve, thevalve flaps 624 can return to their normal positions, as describedbelow, and thereby re-establish the desired pressure differentialbetween the ports.

In the idle state, the flow restricting valve 618 presents a minimal gapand/or opening 626 between its elements or flaps 624. When the suctionadapter 600 is connected to a source of suction, the atmosphericpressure drops in the proximal side of the flow restricting valve wherethe device port 614 and the suction source port 610 are located. Sincethe pressure on the distal end of the flow restricting valve, i.e.,where the endoscopic port is located, is now higher, the flaps 624 ofthe flow restricting valve 618 are pushed towards the proximal end bythe suction flow. This causes the gaps and/or opening 626 between theflaps 624 to increase until a constant flow rate and pressuredifferential is achieved. The suction or negative pressure on theproximal side is now a fraction of the maximum suction, i.e., thesuction available if the flow restricting valve was plugged. Thus, byadjusting the flow rate at the flow restricting valve 618, both deviceports 612, 614 can effectively share a single suction or vacuum source.

Manifold 602 may be made of any suitable bio-compatible material ormaterials. For instance, the manifold may be made of one or morebio-compatible plastic materials. Similarly, the flow restricting valve618 may also be made of any suitable bio-compatible material ormaterials, preferably a bio-compatible plastic material. In a preferredembodiment, the manifold is manufactured of plastic by injection moldingand all features are molded in one piece. However, the manifold could beformed from two or more separately manufactured pieces. For instance,the endoscope port could be attached to a simple tee-connector, whichtee-connector provides the suction source port and the other deviceport. Further, the manifold could be manufactured separately from, orintegrally with, the flow restricting valve. In a further preferredembodiment, the manifold and flow restricting valve are integrallymanufactured by injection molding.

There have been described and illustrated herein several embodiments ofa multiple sample endoscopic biopsy instrument and several embodimentsof a suction adapter. While particular embodiments of the invention havebeen described, it is not intended that the invention be limitedthereto, as it is intended that the invention be as broad in scope asthe art will allow and that the specification be read likewise.

Therefore, for instance, while a particular manner of coupling theproximal actuation handle to the distal assembly has been disclosed forthe several embodiments, it will be appreciated that other manners ofcoupling the proximal and distal assemblies may be used as well.

Furthermore, while the stationary jaw is disclosed as preferably beingmade of plastic and the movable jaw is disclosed as being made of metalit will be appreciated both the stationary jaw and the movable jaw maybe made from plastic, metal, or another material. Moreover, while themovable jaw is disclosed as preferably being made from cast metal, itwill be appreciated that the movable jaw, when made of metal, mayalternatively be made by machining or M.I.M.

Further, while both jaws are shown without teeth, one or both of thejaws may include teeth along their mating surface. In fact, the teethmay be arranged radially as disclosed in co-owned U.S. Pat. No.5,507,296.

Also, while one or two pull wires are disclosed with respect to certainembodiments, it will be appreciated that in each embodiment either oneor two pull wires may be used, in manners described herein.

Furthermore, while the stationary jaw is disclosed as being coupled tothe aspiration tube and the movable jaw is disclosed as being coupled tothe irrigation conduit, it will be appreciated that the stationary jawmay be coupled to the irrigation conduit and the movable jaw may becoupled to the aspiration conduit. Moreover, it will be appreciated thatboth the jaws may be movable about the distal end of the tubular member.In addition, while particular configurations have been disclosed inreference to coupling the proximal actuation handle to the tubularmember, it will be appreciated that other configurations can be used aswell.

It will therefore be appreciated by those skilled in the art that yetother modifications could be made to the provided invention withoutdeviating from its spirit and scope as so claimed.

1. A suction system, comprising: a suction source; a first medicaldevice; a second medical device; a manifold having at least three ports,the ports including a suction port connected to the suction source, afirst device port accommodating the first medical device to receivesuction from the suction source and adapted to be inserted into a bodylumen for performing a first procedure, and a second device portaccommodating the second medical device to receive suction from thesuction source and adapted to be inserted into the body lumen forperforming a second procedure; and a flexible flow valve having anopening positioned in both a first flow path between the first deviceport and the second device port and a second flow path between the firstdevice port and the suction port, the flexible flow valve permittingsimultaneous fluid flow between the suction port and both the first andsecond device ports, wherein the fluid flow path between the suctionport and the first device port is through the opening of the flexibleflow valve, wherein the opening is configured to increase due to fluidflow from the first device port to the suction port.
 2. The suctionsystem of claim 1, wherein the first medical device is an endoscope, andthe second medical device is a suction device.
 3. The suction system ofclaim 1, wherein the flexible flow valve includes a membrane.
 4. Thesuction system of claim 3, wherein the membrane has at least threeflaps.
 5. The suction system of claim 4, wherein the flaps are separatedfrom each other by cuts in the membrane.
 6. The suction system of claim4, wherein the flaps are separated from each other by folds in themembrane.
 7. The suction system of claim 4, wherein the flaps overlap.8. The suction system of claim 4, wherein the opening of the flexibleflow valve includes gaps between the flaps.
 9. The suction system ofclaim 1, wherein the flexible flow valve includes a plurality of firstflaps each having a first shape and alternating with a plurality ofsecond flaps each having a second shape, the first shape differing fromthe second shape.
 10. The suction system of claim 9, wherein theflexible flow valve includes a membrane and the flaps are separated fromeach other by cuts in the membrane.
 11. The suction system of claim 9,wherein the flexible flow valve includes a membrane and the flaps areseparated from each other by folds in the membrane.
 12. The suctionsystem of claim 1, wherein the opening of the flexible flow valve issubstantially centrally located.
 13. The suction system of claim 1,wherein the flexible flow valve is substantially flat.
 14. The suctionsystem of claim 1, wherein the flexible flow valve is conical.
 15. Thesuction system of claim 1, wherein the flexible flow valve isdome-shaped.
 16. The suction system of claim 1, wherein the flexibleflow valve is multi-prism shaped.
 17. The suction system of claim 1,wherein the manifold and the flexible flow valve are manufactured as asingle component.
 18. The suction system of claim 17, wherein themanifold and the flexible flow valve are made of injection-moldedbio-compatible plastic.
 19. The suction system of claim 1, wherein themanifold includes two separately manufactured components, the componentsincluding a first component which includes the first device port and asecond component which includes the suction port and the second deviceport.
 20. The suction system of claim 19, wherein the second componentis a tee-connector.
 21. The suction system of claim 1, wherein themanifold has a third device port configured for accommodating a thirdmedical device.
 22. The suction system of claim 21, including a secondflexible flow valve with an opening, the second flexible flow valvelocated between the third device port and both the second device portand the suction port.
 23. The suction system of claim 1, wherein theopening is configured to increase due to a difference in pressure atproximal and distal sides of the flexible flow valve.
 24. The suctionsystem of claim 1, wherein the opening is configured to increase due toan application of suction.